VASOTEC Drug Patent Profile

When do Vasotec patents expire, and what generic alternatives are available?

Vasotec is a drug marketed by Biovail Labs Intl and Bausch and is included in two NDAs.

The generic ingredient in VASOTEC is enalapril maleate. There are twenty-seven drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the enalapril maleate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Vasotec

A generic version of VASOTEC was approved as enalapril maleate by HERITAGE PHARMA on August 22^nd, 2000.

Summary for VASOTEC

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	8
Patent Applications:	5,234
Drug Prices:	Drug price information for VASOTEC
What excipients (inactive ingredients) are in VASOTEC?	VASOTEC excipients list
DailyMed Link:	VASOTEC at DailyMed

See drug prices for VASOTEC

See drug sales revenues for VASOTEC

Recent Clinical Trials for VASOTEC

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Wisconsin, Madison	Phase 4
Novartis Pharmaceuticals	Phase 4
Brigham and Women's Hospital	Phase 4

See all VASOTEC clinical trials

Pharmacology for VASOTEC

Drug Class	Angiotensin Converting Enzyme Inhibitor
Mechanism of Action	Angiotensin-converting Enzyme Inhibitors
Physiological Effect	Decreased Blood Pressure

US Patents and Regulatory Information for VASOTEC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Biovail Labs Intl	VASOTEC	enalaprilat	INJECTABLE;INJECTION	019309-001	Feb 9, 1988		DISCN	Yes	No
Bausch	VASOTEC	enalapril maleate	TABLET;ORAL	018998-002	Dec 24, 1985	AB	RX	Yes	No
Bausch	VASOTEC	enalapril maleate	TABLET;ORAL	018998-005	Jul 26, 1988	AB	RX	Yes	No

Expired US Patents for VASOTEC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Biovail Labs Intl	VASOTEC	enalaprilat	INJECTABLE;INJECTION	019309-001	Feb 9, 1988	4,374,829*PED
Bausch	VASOTEC	enalapril maleate	TABLET;ORAL	018998-003	Dec 24, 1985	4,374,829*PED
Bausch	VASOTEC	enalapril maleate	TABLET;ORAL	018998-002	Dec 24, 1985	4,374,829*PED

EU/EMA Drug Approvals for VASOTEC

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Proveca Pharma Limited	Aqumeldi	Enalapril maleate	EMEA/H/C/005731Treatment of heart failure.	Authorised	no	no	no	2023-11-15

International Patents for VASOTEC

See the table below for patents covering VASOTEC around the world.

Country	Patent Number	Title	Estimated Expiration
New Zealand	192312	CARBOXYALKYL DIPEPTIDE DERIVATIVES AND PHARMACEUTICAL COMPOSITIONS
Germany	2966767
Yugoslavia	42655

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: VASOTEC

Last updated: July 30, 2025

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Introduction

VASOTEC, the brand name for enalapril, is a cornerstone medication in the treatment of hypertension and heart failure. As an angiotensin-converting enzyme (ACE) inhibitor, VASOTEC belongs to a class of drugs that revolutionized cardiovascular medicine since their inception in the 1980s. Its longstanding presence in the pharmaceutical landscape is driven by robust clinical efficacy, established safety profiles, and expanding patient populations. Nonetheless, the evolving market dynamics — including generic competition, regulatory changes, emerging therapies, and digital health integration — shape its current and future financial trajectory.

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Market Overview and Current Position

VASOTEC remains a key player globally, with market presence in North America, Europe, Asia-Pacific, and emerging markets. The drug’s distribution spans multiple healthcare settings, from primary care to specialty clinics, reflecting its broad therapeutic application. Its original patent expiry in many jurisdictions catalyged a surge in generic formulations, intensifying competition but also broadening access and affordability.

In 2022, the global ACE inhibitor market was valued at approximately $3.5 billion, with VASOTEC accounting for significant portions due to its early market entry and proven efficacy [1]. However, market share distribution varies regionally, influenced by local patent statuses, healthcare policies, and physician prescribing habits. The drug’s success is reinforced by extensive clinical trials and long-term safety data, fostering trust among clinicians.

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Market Dynamics Influencing VASOTEC

1. Patent Expiry and Generic Competition

The patent expiration of VASOTEC in key markets introduced a wave of generic competitors, leading to substantial price erosion. Generic versions often sell at 20-30% of the brand-name price, significantly affecting revenue streams for originators. This shift necessitates pharmaceutical companies to pivot towards volume-driven strategies, cost-efficiency, and portfolio differentiation.

2. Regulatory Environment

Regulatory agencies such as the FDA and EMA influence VASOTEC’s market trajectory through approval processes, post-market surveillance, and labeling updates. Accelerated approval pathways and evolving guidelines for hypertension management can either facilitate market access or introduce new safety monitoring requirements, impacting distribution and sales.

3. Market Penetration and Adoption

Clinician adoption of VASOTEC is driven by its well-established efficacy, with guidelines recommending ACE inhibitors as first-line therapy for hypertension and certain heart failure populations. However, prescriber preferences are shifting towards newer agents — such as angiotensin receptor blockers (ARBs), such as losartan — which offer similar efficacy with potentially fewer side effects like cough.

4. Competitive Therapeutic Landscape

Emerging drugs in the cardiovascular portfolio, including direct renin inhibitors (e.g., aliskiren) and novel antihypertensives, pose competitive threats. Moreover, the rise of combination therapies, integrating ACE inhibitors with diuretics or calcium channel blockers, reshapes market share dynamics.

5. Digital and Personalized Medicine

The integration of digital health devices (e.g., blood pressure monitors linked with patient apps) improves adherence and monitoring. Personalized medicine approaches tailor therapy choices, increasingly favoring newer agents or combination therapies over traditional drugs like VASOTEC.

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Financial Trajectory and Revenue Outlook

Historical Revenue Trends
Since its market introduction in the late 1980s, VASOTEC’s revenue was initially driven by brand dominance, with peak sales reaching over $1 billion annually in the early 2000s. Post patent expiration, revenue declined sharply due to generic entry, with estimates indicating a drop of approximately 70% within a decade. Nonetheless, it maintained a significant market share in certain regions, especially where branded formulations retained a price premium and prescriber loyalty.

Current Revenue Drivers
In 2022, VASOTEC's revenue was estimated at $350-400 million globally, with the majority derived from legacy markets such as the US, Europe, and Japan. Growth is primarily supported through lower-cost generic formulations and expanding access in low- and middle-income countries.

Future Revenue Projections
Multiple factors inform the future financial trajectory:

• Patents and Exclusivity: Most jurisdictions have exhausted patent protections, reinforcing reliance on generics; however, certain markets may have additional extensions or secondary patents on formulations or delivery mechanisms.

• Market Expansion: Investment in generic production facilities, alongside strategic partnerships in emerging markets, could stabilize revenues, especially in countries with growing hypertension prevalence.

• Brand Reinforcement and New Formulations: Companies may develop novel formulations (e.g., sustained-release, combination products) or repurpose VASOTEC for additional indications (e.g., diabetic nephropathy), potentially enabling premium pricing.

• Pricing Trends: U.S. Medicare and private payers' emphasis on cost-effective therapies favor generics, constraining price growth but expanding patient access. Considerations for value-based pricing models are increasingly relevant.

• Competitive Innovation: The advent of novel antihypertensives and combination therapies provides alternative options, potentially limiting VASOTEC’s growth. However, its entrenched safety profile maintains its relevance for certain patient subgroups.

Forecast Summary
Considering these factors, VASOTEC’s global revenue is projected to stabilize or decline modestly in the next five years, with a CAGR of approximately -2% to 0%, primarily due to generic competition. Meanwhile, specific regional markets might experience slight upticks owing to increased access, especially in cost-sensitive settings.

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Strategic Market Opportunities and Challenges

Opportunities:

• Generic Market Penetration: Expanding manufacturing capabilities and supply chain efficiencies can optimize margins.
• Combination Therapy Development: Incorporating VASOTEC into fixed-dose combinations may enhance adherence and justify higher prices.
• Emerging Markets: Growing hypertension prevalence and limited existing infrastructure favor increased sales, especially with pricing strategies suited to local economies.
• Lifecycle Management: Developing formulations with improved pharmacokinetics or reduced pill burden can extend market relevance.

Challenges:

• Market Saturation: Mature markets offer limited expansion potential, emphasizing the importance of innovation.
• Price Pressure: Payers’ emphasis on cost containment reduces revenue potential in high-volume generics.
• Competitor Innovation: ARBs and novel antihypertensives encroach upon VASOTEC’s core indications, risking market erosion.
• Regulatory Hurdles: Stringent approvals for new formulations or indications could delay market entry or restrict sales.

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Conclusion

VASOTEC's market landscape is characterized by maturity, intense generic competition, and incremental innovation. While its historical financial dominance has waned due to patent expiry and market saturation, strategic expansion into emerging markets, formulation innovations, and integration into combination therapies present opportunities for sustained revenue streams.

The drug's future financial trajectory hinges on navigating competitive pressures, regulatory environments, and evolving treatment paradigms—necessitating a focus on lifecycle management, regional expansion, and value-based pricing.

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Key Takeaways

• VASOTEC remains a pivotal, yet mature, product within cardiovascular therapeutics, with revenues driven mainly by generic formulations.
• Patent expirations have led to significant revenue declines; subsequent growth relies on market expansion and formulation innovations.
• Competitive landscape is intensifying with newer agents (ARBs, direct renin inhibitors) and combination therapies, influencing prescribing habits.
• Emerging markets present substantial growth opportunities due to increasing hypertension prevalence and cost-sensitive healthcare systems.
• Strategic investments in lifecycle management and regional diversification are essential for optimizing financial outcomes.

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FAQs

1. What factors primarily influence the decline in VASOTEC’s revenues post-patent expiry?
   Patent expiration enables generic competitors, which offer similar efficacy at lower prices, leading to significant market share erosion and revenue decline for the original brand.

2. Are there any new formulations or indications for VASOTEC?
   While no recent high-profile innovations have emerged, modifications like sustained-release formulations or fixed-dose combinations could extend its utility and attractiveness, though regulatory approval is needed.

3. How does the competitive landscape impact VASOTEC’s future market share?
   Emerging therapies such as ARBs and innovative antihypertensives challenge VASOTEC’s dominance; however, its established safety and clinician familiarity sustain its relevance in specific populations.

4. What role does emerging market growth play in the future of VASOTEC?
   Emerging markets with rising hypertension prevalence and limited access to newer drugs offer substantial growth opportunities, especially through affordable generic options.

5. What strategies can pharmaceutical companies employ to prolong VASOTEC’s market relevance?
   Investing in formulation improvements, exploring new combination therapies, expanding manufacturing capabilities, and targeting underserved regions are key strategies for sustained relevance.

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References

1. MarketResearch.com. (2022). Global ACE Inhibitors Market Report.